Events

LIFEPAK 15 Monitor/Defibrillator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Physio-Control Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00102-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00102-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Physio-control has become aware of a potential device issue where the lifepak 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (relay) installed on the therapy printed circuit board assembly (pcba). a malfunction of the relay can be identified during the user test of the device. if the user test fails, the device will illuminate the service indicator icon on the device. if the user test passes, the device is safe to use.
  • 조치
    Physio-Control is contacting customers with LIFEPAK 15 devices that contain the potentially affected Relay component to arrange for a device correction. This correction will include the replacement of the Therapy PCBA. If needed, loaner devices will be made available while the repairs are being made. In the interim, users are advised to continue to perform the User Test as outlined in the Daily Operator’s Checklist within the LIFEPAK 15 Operating Instructions. If the device fails the User Test, contact Physio-Control immediately to arrange for correction of the device. This action has been closed-out on 25/05/2017.

Device

LIFEPAK 15 Monitor/Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    LIFEPAK 15 Monitor/DefibrillatorSerial Numbers: 44449825, 44452220, 44460124ARTG Number: 215648
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA